Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of nerve growth factor or edaravone on alcohol-induced brain injury

Conditions: Alcohol-induced Brain Injury

Summary: alcohol is one of most common harmful substance, and alcohol intake brings great burden on health worldwide. excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment. although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies, there is no relevant clinical trial about their efficacy and safety on patients. since nerve growth factor and one of the antioxidative medication, edaravone, have been used in some neural diseases in clinical trials, we tend to evaluate the efficacy and safety of nerve growth factor, or edaravone on alcohol-induced brain injuries. the study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly: (1) regular treatment (combination of vitamin b1, b6, c, e and mecobalamine) with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months; (2) regular treatment (rt) with edaravone for 2 weeks and subsequently rt for 6 months; (3) rt alone for 6 months. the patients will be followed up for 6 months. cognitive functions, recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study.


Eligibility criteria:
inclusion criteria: * diagnosis as alcohol dependence according to dsm-iv criteria * mri-proved demyelinating lesions or atrophy in the brain of the patient * no definite history of neurological diseases and psychological problems * volunteer to participate the study, cooperate to be followed up exclusion criteria: * acute withdrawal state and ciwa score \> 9 * with other neurological diseases and psychological problems * with ever brain trauma and damage * with other psychological medications or other substance dependence

Keywords: alcohol-induced brain injury, atrophy, demyelination
improving safety in pediatric thyroidectomy by pth measurements

Conditions: Hypoparathyroidism Postprocedural

Summary: we implemented a previously reported algorithm based on intra-postoperative pth measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. the objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.

sixty-six patients were included in the analysis. based on their intra-operatory pth determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin d1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). the outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when tca levels dropped below normal. in the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p\<0.001), and the median hospitalization length from 6 to 3 days (p\<0.001). in the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p\<0.001). eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (rr: 2.1 \[ci 95% 1.4-3.1\], p\<0.001). compared to the control group, overall incidence of hypocalcemia was reduced by 58 %. this approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.

Eligibility criteria:
inclusion criteria: * patients who underwent total thyroidectomy between january 2014 and april 2020 exclusion criteria: * patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect tca, pth, or vitamin d levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism

Keywords: thyroidectomy pth pediatric surgery hypocalcemia
cpvi plus renal sympathetic modification versus cpvi alone for af（atrial fibrillation） ablation

Conditions: Atrial Fibrillation

Summary: the study is designed as a randomized control trial. the purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (cpvi) plus renal sympathetic modification (rsm) with cpvi alone.

basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. present studies of renal ablation show a new method to decrease sympathetic nerves activity. circumferential pulmonary vein isolation (cpvi) is an accepted ablation method for atrial fibrillation. the investigators plan to evaluate the efficiency and safety of cpvi plus renal sympathetic modification for atrial fibrillation ablation comparing with cpvi alone. the trial is going to recruit 100 patients randomized into two groups (cpvi+rsm group vs cpvi group = 50:50) with a follow-up duration of 4 years. the investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with cpvi alone.

Eligibility criteria:
inclusion criteria: * • ≥ 18 years old, and ≤ 75 years old of age * more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ecg proved * be ineffective to at least one kind of anti-arrhythmic drugs treatment * echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy * estimated glomerular filtration rate (egfr) of ≥ 45ml/min * is competent and willing to provide written, informed consent to participate in this clinical study exclusion criteria: * • transesophageal echocardiography found thrombus in left atrial appendage * past history of atrial fibrillation surgical maze procedure * estimated glomerular filtration rate (egfr) of \< 45ml/min * has the history of renal restenosis or renal stents implantation * has experienced ami（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months * patients with sick sinus syndrome * pregnant women * mental disorders * patients that have allergy to contrast agent * patients that do not go with follow-up * others such as researcher considers it is not appropriate to be included into the study

Keywords: atrial fibrillation
effects of vitamin d on renin expression in hypertensive patients

Conditions: Hypertension; Vitamin D Deficiency

Summary: the cardiovascular effects of vitamin d therapy (in humans) have been documented only in patients with known vitamin d deficiency or hyperparathyroidism (a surrogate marker of inadequate vitamin d activity). it is unknown whether the cardiovascular benefits of vitamin d therapy extend beyond these patients to the general hypertensive population. we propose to directly measure the effect of vitamin d therapy on plasma renin activity (pra), plasma renin concentration (prc), renin transcription (in mononuclear leukocytes), and blood pressure in hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental trial. this will be the first study to assess vitamin d receptor (vdr) biological (pra, prc, renin mrna, and polymorphisms) and hypertensive activity in patients without vitamin d deficiency. we hypothesize that vitamin d inhibition of renin transcription will produce significant reductions in pra, prc, renin transcription, inflammatory cytokines, sbp, and dbp, with potential variation by vdr genotype. such a result may prove to be significant in the treatment of hypertension, as even modest blood pressure reductions (5 mmhg) are associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due to chd, and a 7% overall reduction in all-cause mortality.


Eligibility criteria:
inclusion criteria: 1. male or female patients age \> 55 years. 2. female patients must be postmenopausal, as determined by surgical hysterectomy or 12 month history since last active menstruation 3. stage i hypertension (jnc vii criteria): mean systolic blood pressure (msbp) 140-159 mmhg and mean diastolic blood pressure 90 - 99 mmhg (mdbp)2 4. provide informed consent exclusion criteria: 1. serum vitamin d \<55 pmol/l 2. serum calcium \>10.5 mg/dl 3. serum phosphate (inorganic) \>5.5 mg/dl 4. serum parathyroid hormone (pth) \>1.3 pmol/l 5. vitamin d supplements, calcium supplements, estrogen replacement therapy, corticosteroids (inhaled/oral), or hydroxymethyl glutarate coa reductase inhibitors (statins) within 30 days prior to randomization 6. stage ii hypertension (jnc vii criteria): mssbp \>160 mmhg or msdbp \>100 mmhg 7. use of alpha2-agonists, beta-blockers, or more than 2 anti-hypertensive medications at screening 8. estimated creatinine clearance \<30 ml/min by crockroft-gault formula 9. history of heart failure (hf), acute myocardial infarction (ami), acute coronary syndrome (acs), transient ischemic attack (tia), cerebrovascular accident (cva), peripheral vascular disease (pvd), or known clotting disorder 10. insulin dependent diabetes mellitus (patients stabilized on oral regimens may be enrolled) 11. history of hypersensitivity reaction to 1α, 25-(oh)2 vitamin d3 (calcitriol)
a study of factor xiii concentrate in subjects with congenital factor xiii deficiency

Conditions: Factor XIII Deficiency

Summary: congenital deficiency of factor xiii (fxiii) is an extremely rare inherited disorder associated with potentially life-threatening bleeding. factor xiii concentrate is given to patients whose blood is lacking factor xiii. factor xiii concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. in this study, patients will be treated with fxiii concentrate (human) and followed closely to determine that they receive the dose that will best minimize the chance of bruising and bleeding.


Eligibility criteria:
inclusion criteria: * written informed consent/assent for study participation obtained before undergoing any study-specific procedures * documented congenital fxiii deficiency which requires prophylactic treatment with a fxiii containing product. * males and females of any age with congenital fxiii deficiency * received full hepatitis b vaccination and/or is hepatitis b surface antibody positive exclusion criteria: * diagnosis of acquired fxiii deficiency * administration of a fxiii-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned day 0 * any known congenital or acquired coagulation disorder other than congenital fxiii deficiency * known or suspected to have antibodies towards fxiii * use of any other investigational medicinal product within 4 weeks prior to the baseline visit (day 0) * known positivity for human immunodeficiency virus (hiv) or a positive result for hiv at the screening visit of this study or the fxiii study 2002 (nct00883090). * serum aspartate transaminase (ast) or serum alanine transaminase (alt) concentration \>2.5 times the upper limit of normal at the screening visit of this study or at the day 56 visit of factor xiii study bi71023_2002 (nct00883090) * fibrinogen level less than 85% of the lower limit of normal at the screening visit of this study or the factor xiii study bi71023_2002 (nct00883090) * active bleeding ≥ common terminology criteria for adverse events (ctcae) grade 2 and/or ≥ moderate between the screening and baseline visits * pregnant or breast-feeding * intention to become pregnant during the course of the study * female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study * suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance

Keywords: hereditary factor xiii deficiency factor xiii
real-time kv imaging vs. real-time 3d patient surface tracking for head & neck cancer

Conditions: Head and Neck Cancer

Summary: to determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.


Eligibility criteria:
inclusion criteria: * patients with hnc undergoing radiation therapy at stanford university * age \>= 18 years old * radiation course \>= 4 weeks duration * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device. * patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.
nicotine vapor specific sensory measurement

Conditions: Substance-Related Disorder

Summary: this trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.

primary objective: i. study that flavors might be related to the phenomenon of 'indirect' toxicity. outline: participants are randomized to 1 of 2 conditions. condition i: participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations). condition ii: participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).

Eligibility criteria:
inclusion criteria: * current daily vapers of products containing nicotine * no concurrent use of other tobacco products * self reported general good health * no allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures * no self-reported taste or smell deficits * not pregnant or lactating * no medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc) * passing scores on the phenylthiocarbamine (ptc) and 6-n-propylthiouracil (prop) smell and taste tests * access to video-conference or telephone * ability to store test products in a secure location away from children exclusion criteria: * not current daily vapers * concurrent use of other tobacco products * self-reported fair or poor general health * allergies - active untreated seasonal allergies that would interfere with smell or taste procedures * self-reported taste or smell deficits * pregnant or lactating * medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc) * failing scores on the phenylthiocarbamine (ptc) and 6-n-propylthiouracil (prop) smell and taste tests * no access to video-conference or telephone * unable to store test products in a secure location away from children * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners * adults unable to consent * adults unable to legally purchase tobacco products in new york (ny) state (18-20)
a trial to test for bioequivalence between nn1045 and nn5401 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (idegasp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer * body mass index from 18.0 to 28.0 kg/m\^2 (both inclusive) * hba1c below or equal to 9.5% by central laboratory analysis exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
study comparing the use of laser and of kinesiotherapy for the treatment of female stress urinary incontinence

Conditions: Urinary Stress Incontinence

Summary: the purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence

the objective of this project is to compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence. a randomized controlled clinical trial is proposed involving 40 women diagnosed with stress urinary incontinence randomized into two groups: 1) treatment with application of erbium laser: yag 2940nm, smooth mode, one session per month for three months (n=20); 2) treatment with kinesiotherapy for three months with supervision twice a week (n=20). at baseline assessment, patients shall undergo anamnesis, general physical and gynecological exam, assessments of the pelvic floor based on the modified oxford scale and of the presence of prolapse using the pelvic organ prolapse quantification (pop-q) system. the following exams shall also be performed: type 1 urine, urine culture, urodynamic study and 1-hour pad test. participants shall complete both the king's health questionnaire and incontinence quality of life questionnaire (iqol). post-treatment, patients will be assessed during follow-up visits at 1, 3, 6 and 12 months by physical exam and application of the questionnaires. the pad test will be re-administered at 6 and 12 months. data will be grouped and statistically assessed.

Eligibility criteria:
inclusion criteria: * post-menopausal women with stress urinary incontinence will be recruited for this study. exclusion criteria: * patients presenting detrusor hyperactivity,stress urinary incontinence with sphincter deficiency genital prolapse, stages 3 and 4 on the pop-q system, genital cancer, history of painful bladder syndrome, previous history of radiotherapy, keloid, use of photosensitive drugs, uncontrolled diabetes mellitus, active vaginal infection (bacterial vaginosis and candidiasis), abnormal genital bleeding or vaginal stenosis shall be excluded.

Keywords: urinary stress incontinence urinary incontinence,stress laser physiotherapy kinesiotherapy
a study of the safety of vonoprazan exposure in pregnant women and their offspring

Conditions: Erosive Esophagitis; Heartburn; Symptomatic Non-erosive Gastroesophageal Reflux Disease; Helicobacter Pylori Infection

Summary: the main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.


Eligibility criteria:
inclusion criteria: * women 15 to 50 years of age. * currently or recently pregnant. * consent to participate. * authorization for her health care provider(s) (hcp\[s\]) to provide data to the registry. * exposed cohort: exposure to at least one dose of vonoprazan during pregnancy. * unexposed cohort: unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed. exclusion criteria: * occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (vrcc) (retrospectively enrolled). * exposure to known tetratogens and/or investigational medications during pregnancy. * lost to follow-up.

Keywords: erosive esophagitis heartburn symptomatic non-erosive gastroesophageal reflux disease helicobacter pylori infection pregnant women fetal infant
inhibition effects of probiotics on pathogens associated with vap

Conditions: Ventilator Associated Pneumonia

Summary: this study evaluates that p. aeruginosa, a. baumannii, k. pneumonia and staph aureus which are obtained from patients' tracheal aspiration culture who treated with mechanical ventilation will be compared with lactobacillus (lab) members and nisin bactriocin in the laboratory. the aim is to investigate the probiotics' antimicrobial properties and effects on these bacteria's growth rate.

ventilator associated pneumonia (vap) is one of the most commonly seen hospital-acquired infections that occurs in patients who receive mechanical ventilation. vap usually occurs 48-72 hours after mechanical ventilation and is related increased incidence of multidrug-resistant infections, increased antibiotic use, extended mechanical ventilation time, increased patient stay in the intensive care unit (icu), and increased patient stay in the hospital. one recent intervention is the probiotic therapy which is a nonantibiotic strategy for maintenance of the host's aerodigestive microbial balance and vap prevention.common causative pathogens of vap include gram negative bacteria such as pseudomonas aeruginosa, klebsiella pneumoniae, and acinetobacter species, and gram-positive bacteria such as staphylococcus aureus. in this study, these gram negative pathogens obtained from mechanical ventilated patients' tracheal aspiration culture and reference bacteria strains will be compared with lactobacillus (lab) members and nisin in the laboratory. probiotics' antimicrobial properties and effects on these bacteria's (obtained from patients and reference strains) growth rate will be investigated.

Eligibility criteria:
inclusion criteria: * patients who mechanically ventilated at least 48 hours in the intensive care unit exclusion criteria: * patients who mechanically ventilated less than 48 hours